DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/14/2025 has been entered.
Response to Amendment
The Amendment filed 06/17/2025 has been entered. Applicant’s amendments are in response to in the Final Office Action mailed 04/18/2025. Applicant has amended the claim set to specific the formulation type of the composition of independent claim 1, and specific a method outcome of independent claim 8 to draw a new grounds of rejection. Claims 9 and 20 are cancelled. The 101 and 103 rejections have been modified to more precisely address Applicant’s arguments and amendments. The amendments and arguments have not been found persuasive in view of the Prior Art.
The Examiner further acknowledges the following:
Claims 1-2, 4, 6-8, 10-13, 15-19, and 21-22 are pending.
Claims 1-2, 4, 6-8, 10-13, 15-19, and 21-22 are presented for examination and rejected as set forth below.
Claim Objections
Claims 1-2, 12, and 15-18, recite unusual symbols (i.e., “(#1)”, “(#2)”, etc.). Remove the symbols and replace them (if needed) with the terms or phrases they represent that demonstrate proper antecedent basis (incorporating articles such as “a”, “the”, “said”, etc.). Correction is required.
New Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 4, 6-7, 17-19, and 21-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature or natural phenomenon without significantly more.
Claims 1-2, 4, 6-7, 17-19, and 21-22 recite a composition that comprises plant extracts from genus Salvia, Artemisia, Echinacea, and Equisetum. Because the mixture does not exist naturally in nature, the individual component plant extracts are considered. There is no evidence within the specification that the compositions recited in claims 1-2, 4, 6-7, 17-19, and 21-22 contain markedly different characteristics from their naturally-occurring counterparts. The composition of claim 1 appears to claim a composition that simply mixes three natural plant extracts together, where the “wherein” formulation clause still only recites (for example) a liquid formulation (which could include a simple water solution). Therefore, the instant claims recite a product of nature.
While extraction of the compounds with a solvent would separate a portion of the plant matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the plant material; i.e., the compound is not inventive or “man-made.” There is no evidence or reason to expect that any new compounds are formed during extraction. Furthermore, the addition of natural or synthetic additives to the natural extract composition does not necessarily mean a change in the structure, function, or other properties of the extracts in any marked way in comparison with the closest naturally occurring counterpart. For claim 1, altering the concentration of the claimed ingredients does not appear to change its structure or function and therefore does not appear to result in a markedly different characteristic for the composition. For claim 4, regarding the presence of cosmetic excipients, it is well-understood, routine, and conventional in the field to combine the claimed extracts with cosmetic excipients for topical compositions (Ragot, US 2015/0056255A1).
For claim 1, liquid formulations are conventional (e.g., aqueous or oily solutions, lotions, milks) and don’t appear to result in a marked difference. Although Applicant is close to fulfilling the guidance, there is still formulations that are barred from allowability (e.g., an oil formulation), wherein the mixing of an oil with the plant extracts does not provide a structural and/or controlled release modification affecting the naturally-occurring actives (see section on “Vaccines comprising Peptide F” on pg 63, paragraph 1 and pg 67, paragraph 2 in USPTO Examples (2016) – where emulsification is required for a structural difference, as compared to oil or water used in their natural state, where the formulation would simply slide off of the patient’s skin). The SME document does not give guidance on lotions, milks, foams, sprays. Foams and sprays have structure. However, DermWeb (2007) defines “lotion” in a way where lotion could be any liquid preparation with an active medication dissolved. Thus, the formulation of lotion does not appear to impart a structural or controlled-release functional change to the naturally-occurring active. Furthermore, Quora (2018) teaches that milks and lotions are comparable formulations that are not necessarily emulsions (pg 1, Kelley Spartiatis). For claims 6-7 and 21, specifying the origin of the extract does not resolve the deficiency. For claim 22, intended use does not affect the structure of the composition claimed.
This judicial exception is not integrated into a practical application because the instantly amended claims do not introduce any additional limitations which transform or improve on the judicial exceptions recited in claims 1-2, 4, 6-7, 17-19, and 21-22 and do not do anything beyond generally linking the use of the judicial exception to a particular technological environment.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because compositions comprising the instantly claimed ingredients, are well-understood as possessing routine, and conventional activity. Plant extracts such as those of the instant claims have been known for use in skin treatment compositions and have skin benefiting properties (Ragot, US 2015/0056255A1). The data does not show the compositions providing any benefit more than the combination of the individual plant extract components. Claims 1-2, 4, 6-7, 17-19, and 21-22 are directed to a judicial exception and do not qualify as eligible subject matter under 35 U.S.C. §101.
New Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 4, 6-8, 10-13, 19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Ragot (US 2015/0056255A1), in further view of Faller (US2008/0260869A1) and Behr (US20070122492 A1).
Applicants claims are directed to a cosmetic preparation (i.e., a composition) that “comprises” various plant extracts at specified amounts and a method of use. It is noted that claims 15-18 name plant extracts of specific species of the instant genera. For claim 22, note that a recitation of an intended use will not limit the scope of the claim because it merely defines a context in which the invention may operate. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Thus, “suitable to stimulate the lymphatic system” describes an intended use of the composition, and is not given weight.
Furthermore, direction for “stimulate the lymphatic system” is found in the Specification on pg 7: “stimulation of the lymphatic system: lymph vessels fulfill an important role in order to maintain the microenvironment surrounding tissue in a constant state by removing unwanted substances present in skin as well as water and protein constantly escaping from blood vessels. It was found that plant extracts as described herein activate the lymphatic system, particularly the lymphatic vasculature” where activation is demonstrated by sprouting and migration of cultured human lymphatic endothelial cells (pg 7, Specification). Applicant demonstrates sprouting at 0.05% and 1% for example (pg 13, Specification).
For the method claims (instant claims 8, 10-13, and 15-16), the phrase “skin in need thereof a cosmetic preparation” is interpreted broadly to mean any skin in need of any cosmetic preparation and does not specify a particular subject population or skin condition for treatment. The skin benefiting method outcomes of instant claim 8 (i.e., to stimulate the lymphatic system, but also rejuvenation of the skin, anti-aging of the skin, etc.) are not given weight in an obviousness rejection. It must be remembered that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005) (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Weight can be provided to a method outcome, if the instant claims are able to argue a new and non-obvious result (the Examiner discusses the method outcome, regarding the lymphatic stimulation, which appears to be the focus of Applicant’s arguments, in the arguments section below).
Furthermore, in the method claims, there is a mix of skin conditions (i.e., puffy eye, swollen skin) which are given weight, and other method outcomes (which are addressed in the paragraph above; i.e., rejuvenation of the skin, anti-aging of the skin, etc.), which are addressed in the rejection below. Note that patentable weight for a method of treatment is afforded to defining patient populations to be treated, , as defined by a disease or skin condition (e.g., puffy eye; however, as shown below, the method of treating puffy using these kinds plant extracts is obvious from the literature).
Ragot discloses a product for medicinal, cosmetic, coloring, or dermatologic use, that comprises one or more plant extracts that can be applied on the skin (Ragot – claims 1-4, [0014]).
Regarding claims 1-2: Ragot teaches a product for dermatologic use (Ragot – claim 1) comprising plant extracts from Artemisia spp., Echinacea angustifolia, Equisetum arvense, and Salvia spp. (which reads on the instant geniuses of instant claims 1-2) (Ragot – claims 5 and 6). Ragot teaches the plant extract to be at least 30% by weight in the composition (Ragot – claim 16), which is near the upper limit of 20 wt% of the instant claims. Furthermore, Ragot teaches that the extract can be concentrated (which could be read as “enrichment”) or purified (Ragot – claim 41, step (e)). Ragot teaches the product to be a cream, a foam, a liquid, or a powder (Ragot – claim 18). Furthermore, with respect to the number of plant genera and species used in topical cosmetic application, named by Ragot: it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).
Regarding claim 4: Ragot teaches incorporation of additional substances, including emulsifiers, scents, preserving agents, vitamins, essential oils, coloring agents, etc. [0088, 0091].
Regarding claims 6-7 and 21: Ragot teaches that the plant extract can come from certain parts of the plant such as the root, bark, leaf, fruit, or flower [0007]. Ragot teaches a method to obtain plant extract, using polar or apolar solvents [0020-0030].
Regarding claim 19: Ragot teaches hyaluronic acid [0066] and collagen [0067].
Regarding claim 22: Stimulation of the lymphatic system is an intended use of the composition, and a recitation of an intended use will not limit the scope of the claim because it merely defines a context in which the invention may operate. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003).
In summary, Ragot teaches a composition comprising elements (including plant extracts) of the instant composition for cosmetic use except for the amounts of claim 1. However, Ragot does not teach the specific amounts (instant claim 1) and the “the method of applying to skin in need thereof a cosmetic preparation” (instant claims 8, 10-13).
Faller teaches topical compositions comprising plant extracts (including artemisia abrotanum) (abstract), where artemisia abrotanum is used in 4 wt% (Table 1) (within the instant amounts of claim 1) but also teaches a very wide range 0-99 wt% of ingredients [0020, 0092] in determining the effective amount of active such that a person would optimize the amount of active [0023, 0028], and this plant extract is known for treatment of puffy eye (reads on puffy eye/swelling of instant claims 8, 10, 11, and 13) [0012-0013, 0054]. Faller teaches a method of applying the composition for skin conditions such as puffy eyes and wrinkles (Faller – claims 33-37 and 44-48).
Behr further teaches cosmetic compositions for skin sagging (abstract) or swelling [0166] that incorporate plant extracts of Echinacea [0197], Artemisia [0197], Salvia [0197], and Equisetum [0197] to treat skin ageing, where the final effective amount of extract used in a composition would be tied to the desired beneficial effect of skin improvement ([0014], [0186], abstract). See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of extract in Ragot’s composition to the amount range taught by Faller because the amount of extract used is typical in the arts for skin improving effects, as in Faller’s teaching. Furthermore, Behr and Faller discuss optimizing amount of plant extract based on desired activity to provide effective skin treatment. It is noted that Ragot desires to achieve a medicinal, cosmetic, or dermatological effect (abstract). Furthermore, the amount of active ingredients within a plant extract is not well defined (as plant extracts can be dilute or concentrated), and thus, a PHOSITA would be expected to optimize the amount of total extract applied in the composition.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to apply Faller’s method of applying a composition to skin in need thereof a preparation for treatment of puffy eye or loss of firmness to Ragot’s teaching because Ragot, Fallers, and Behr both teach compositions comprising plant extracts (including the instant plant genera) intended to treat puffy eye and swelling. Ragot also targets the eyes [0078] and has interest in plants with anti-inflammation, anti-aging, and anti-wrinkle effects [0088, 0106].
With respect to the obviousness of the composition and method, remember that “to stimulate the lymphatic system” is not currently given weight because this is a method outcome and does not represent a limitation that affects the active steps of the method (see claim interpretation above). The discussion regarding the unexpectedness of results will be addressed below in the ‘response to arguments’ section.
Claims 1-2, 4, 6-8, 10-13, 15-19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Ragot (US 2015/0056255A1), Faller (US20080260869A1), and Behr (US20070122492 A1), as applied to claims 1-2, 4, 6-8, 10-13, 19, and 21-22, in further view of Makerri (US20190336884A1).
As discussed above, Ragot, Faller, and Behr teach a cosmetic preparation comprising various species and genus of plant extracts at specified amounts, and a method of applying topically for treatment of skin conditions such as puffy eye or loss of firmness. However, they do not teach all of the specific species of the preparation or the method (instant claims 15-18).
Makerri teaches plant extracts of Salvia Hispanica, Artemisia abrotanum, and Artemisia vulgaris [0075] (where Ragot teaches Artemisia spp., Echinacea angustifolia, Equisetum arvense, and Salvia spp. (Ragot – claims 5 and 6) for cosmetic use) for use in topical dermatological or cosmetic compositions [0028, 0086] where the extract is used in 1x10-4 to 10 wt% in the composition [0087] (also overlapping the instant amounts of claim 1) to improve the health or physical appearance of facial and body skin [0090, 0093].
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ragot’s composition with the plant extract species taught by Makerri because they are specific species of plant genera taught generally by Ragot for the same outcome of skin improvement. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Response to Arguments
Applicants arguments, see pg 6-10, filed 06/17/2025, with respect to the 101 and 103 rejections of claims 1-2, 4-13, and 15-22 (inclusive of the current amendments) are not persuasive. The 101 and 103 rejections have been modified with respect to amendments made to the claim set.
On page 6, Applicant argues for a request of a second non-final on the basis of an improper action by the Office. The Examiner has discussed the position of the Office in the interview (interview summary filed on 06/05/2025). Furthermore, the issue is now moot with the submission of an RCE.
On page 6, Applicant argues claim 1 has been amended to meet the guidance from USPTO Examples (2016). Although Applicant is close to fulfilling the guidance, there is still are formulations that are barred from allowability (e.g., an oil formulation), wherein the mixing of an oil with the plant extracts does not provide a structural and/or controlled release modification affecting the naturally-occurring actives (see section on “Vaccines comprising Peptide F” on pg 66-67 – where emulsification is required for a structural difference, as compared to oil or water used in their natural state, where the formulation would simply slide off of the patient’s skin). Furthermore, the SME document does not give guidance on lotions, milks, foams, sprays; foams and sprays are discussed as having structure. However, DermWeb (2007) defines “lotion” in a way where lotion could be any liquid preparation with an active medication dissolved (pg 3). Thus, the formulation of lotion does not impart a structural or controlled-release functional change to the naturally-occurring active. Furthermore, Quora (2018) teaches that milks and lotions are comparable formulations that are not necessarily emulsions (pg 1, Kelley Spartiatis).
On page 7, with regard to the arguments of using new interpretations of claim language, “there is nothing unusual, certainly, about an examiner changing his viewpoint as to the patentability of claims as the prosecution of a case progresses, and so long as the rules of Patent Office practice are duly complied with an applicant has no legal ground for complaint because of such change in view. The life of a patent solicitor has always been a hard one. In re Ruschig, 154 USPQ 118, 120-21 (CCPA 1967).” In this case, the solidification of the claim interpretation was prompted as a defense to Applicant’s arguments in the previous round of prosecution. Also, the assertion that intended uses are functional language is wholly without merit. “Particularly, a recitation of an intended use will not limit the scope of the claim because it merely defines a context in which the invention may operate. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003).”
On page 7-8 of Applicant’s response, Applicant argues that the method outcome of “stimulation of the lymphatic system” provides patentable weight, because it represents an unexpected outcome of the method. Weight can be provided if the instant claims are able to argue a new and non-obvious result of the method (the method outcome is discussed in detail further below). However, as discussed below, the “stimulation of the lymphatic system” appears to be a property inherent to the plant extracts claimed by Applicant. Within the combined Art, where proper motivation has been applied to combine the references, the instant plant extract species, in which the taught amounts encompass the instant wt% ranges of instant claim 1, are taught as useful in topical cosmetic composition for use in conditions (such as puffy eye, etc.) as found in claims 8 and 10. The phrase “to stimulate the lymphatic system” is merely a property that necessarily occurs when applying the plant extract compositions of the Prior Art. Applicant has only discovered this property, as unappreciated, within compositions of the Prior Art. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unquantified property which is necessarily present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Furthermore, Applicant’s “method of cosmetically treating” in instant claim 8 does not differ from the Prior Art, such that the composition is “applied to skin in need thereof a cosmetic preparation”, where these specified limitations of the method are the same limitations taught by the method of treatment by applying plant extract composition to skin in need thereof a cosmetic preparations from the Art (e.g,, Faller teaches treatment of puffy eye such that a person with a puffy eye is need of a cosmetic preparation for to resolve the puffiness).
Applicant further argues Ragot’s compositions do not stimulate the lymphatic system or teach to stimulate the lymphatic system. As discussed above, stimulation of the lymphatic system is a property inherent of compositions of the Prior Art. Furthermore, stimulation of the lymphatic system necessarily occurs, as discussed above, by the method of applying the Prior Art compositions. Thus, stimulation of the lymphatic system is inherent to the compositions of the Prior Art and methods of applying (see discussion in preceding paragraph).
On page 8, Applicant argues against the Wayback Machine reference (Herbalism Roots). In concession to Applicant’s arguments, reconsideration of Herbalism Roots (2014) in light of related art, suggests that this reference is likely directed to oral application of the herbs (outside of the claim set scope) and not topical, and thus, this reference is withdrawn from consideration. Also, for reference, SA Natural Products (2003) teaches Echinaforce (derived from Echinacea purpurea and Angustifolia plants, pg 3), which stimulates lymph glands (reads on lymphatic activation) (pg 3-4). However, SA Natural Products does not teach skin application, which deviates from applicant’s claim scope and unexpected results, and thus this reference is withdrawn from consideration. As a result of this concession, the arguments addressed to Herbalism Roots are considered moot.
On page 8, Applicant argues Ragot does not provide guidance on selection from the numerous plant species of the disclosure. It is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985). Thus, in an obviousness rejection, the number of species to select from within a primary reference in order to provide a skin benefit is not relevant. Furthermore, Applicant has not demonstrated an unexpected effect from the combination of the multiple plants extracts, as by the Prior Art (such as synergy), and thus, an obvious additive effect would be expected by the combination.
On page 8-9, Applicant argues against the Wayback Machine reference (Herbalism Roots). In concession to Applicant’s arguments, reconsideration of Herbalism Roots (2014) in light of related art, suggests that this reference is likely directed to oral application of the herbs (outside of the claim set scope) and not topical, and thus, this reference is withdrawn from consideration. Also, for reference, SA Natural Products (2003) teaches Echinaforce (derived from Echinacea purpurea and Angustifolia plants, pg 3), which stimulates lymph glands (reads on lymphatic activation) (pg 3-4). However, SA Natural Products does not teach skin application, which deviates from applicant’s claim scope and unexpected results, and thus this reference is withdrawn from consideration. As a result of this concession, the arguments addressed to Herbalism Roots are considered moot.
On page 9, Applicant argues against Popp and Ribeiro, which is no longer relied upon in this rejection. Makerri provides teaches of species of the instant claim, and appropriate rationale is provided to combine references.
On page 9-10, Applicant argues case law with no specific argument.
Correspondence
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/R.P./Examiner, Art Unit 1614 11/3/2025
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614